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Completed

NCT Number: NCT01960335

Whey Protein Intake With and Without Exercise on Visceral Fat: The P+RISE Study

Dietary manipulation is proving to be an effective lifestyle strategy to combat the obesity epidemic. Increased dietary protein is one effective strategy. For example, increased whey protein ingestion with and without exercise training is associated with enhanced weight loss, body composition and subjective hunger in overweight and obese individuals. Our findings suggest that the effects of whey protein ingestion occur independent of a calorie-restricted diet and to a greater extent in individuals following a combined exercise program of resistance exercise, sprint intervals, stretching/yoga/pilates, and aerobic exercise training compared to standard resistance training.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health & Exercise Sciences Department, Human Nutrition and Metabolism Laboratory, Skidmore College

Saratoga Springs, New York, 12866, United States

About this study

This study was a 16 week whey protein and exercise training intervention in middle aged overweight/obese adults. Subjects were randomized into 3 groups: Whey protein only consumed as 20 grams per serving three times per day (total 60 grams per day) (WP); Whey protein and resistance exercise training (WP-RT); and Whey protein and combined exercise training (P+RISE). All outcomes, including the primary outcome of visceral fat was measured at baseline (week 0) and post-intervention (week 17) in all study subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy, overweight or obese, inactive

Exclusion criteria

  • smoker, exercise-trained, recent weight loss, heavy caffeine-consumer

Treatment and study plan

Whey Protein

Dietary Supplement

Whey protein provided in 20 gram servings administered three times per day. once in the morning upon waking; a second serving in the mid-afternoon; and a third serving within 2 hours of going to sleep at night.

Whey Protein and Resistance Exericse

Dietary Supplement

Subjects will receive 20 grams of whey protein three times per day along with 4 days per week of resistance exercise training throughout the 16 week intervention.

Whey Protein and RISE exercise routine

Other

Subjects will consume 20 grams of whey protein three times per day (total of 60 grams) and perform a combination of exercise involving functional resistance exercise (R); sprint intervals (I); stretching/pilates/yoga (S); and endurance exercise (E); RISE four days per week.

Primary outcomes

  1. change in visceral fat

    Time frame: baseline and 17 weeks

Sponsors and collaborators

Lead sponsor

Skidmore College

Other

Registry information

Official study title

Whey Protein With and Without Exercise Training Enhances Total and Regional Body Composition, Insulin, Leptin, and Blood Pressure in Overweight and Obese Adults - The P+RISE Study

Acronym: P+RISE

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 10, 2013
Registry last updated
Oct 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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